Clinical Operations Specialist
hace 3 días
Role Summary
We are looking for a Clinical Operations Specialist to support the successful execution of clinical studies for all Bioscience products, following ICH-GCP guidelines and all applicable regulatory requirements. As a key member of our Clinical Operations team, you will be responsible for developing and improving Clinical Operations processes to increase the department's efficiency and quality standards.
Key Responsibilities
- Develop and improve Clinical Operations processes to increase the department's efficiency and quality standards.
- Communicate and work with other functional groups to identify, review, maintain, align, and improve cross-functional processes throughout the clinical programs.
- Interact with the Clinical Operations department staff and project teams to provide guidance to resolve compliance issues.
- Ensure compliance with GCP/ICH and regulatory guidelines.
Requirements
- Life Sciences Degree or Master and at least 5 years of experience in clinical trials.
- High level of English (C1) and knowledge of ICH GCPs, FDA CFRs, regulatory requirements, and understanding of continuous change in the regulatory environment.
- Familiarity with Clinical Operations processes, systems, and SOPs from the project management point of view.
What We Offer
- Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
- Benefits package and contract of employment: Permanent position with flexibility for U Program: 2 days remote working.
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